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Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00332137
First received: May 30, 2006
Last updated: March 21, 2011
Last verified: March 2011

May 30, 2006
March 21, 2011
September 2005
August 2007   (final data collection date for primary outcome measure)
Colonic transit (as measured by GC24)
Same as current
Complete list of historical versions of study NCT00332137 on ClinicalTrials.gov Archive Site
  • Colonic transit (GC48)
  • Ascending colon emptying t1/2
  • Colonic filling at 6 hours, i.e. a surrogate marker of small bowel transit time
  • Gastric emptying time (1, 2, 4 hours, thalf)
  • Average number of stools per day before and during treatment
  • Colonic transit (GC48)
  • Ascending colon emptying t1/2
  • Colonic filling at 6 hours, i.e. a surrogate marker of small bowel transit time
  • Gastric emptying time (1, 2, 4 hours, thalf)
  • Average number of stools per day before and during treatment
  • Stool consistency before and during treatment
  • Serum anticholinergic activity measured by 3H-QNB assay
Not Provided
Not Provided
 
Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects
Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects

The muscarinic antagonist tolterodine is widely used treat urinary urge incontinence. Though acteylcholine is the primary excitatory neurotransmitter in the gastrointestinal tract, the phase III trials suggest that tolterodine infrequently causes constipation. Therefore, the objectives of this study are to assess if tolterodine affects the speed at which food travels through the stomach, intestines and colon (i.e., gastrointestinal and colonic transit) in healthy subjects.

The specific aims of this study are to test the hypotheses that the non-specific muscarinic antagonist tolterodine will not:- i) delay colonic transit and the proximal colonic emptying rate; ii) delay gastric emptying; nor iii) delay small intestinal transit compared to placebo in healthy subjects.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Health
Drug: Tolterodine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
August 2007
August 2007   (final data collection date for primary outcome measure)

Age 18-70 years old. Absence of gastrointestinal symptoms as characterized by bowel symptoms questionnaire and absence of significant anxiety or depression characterized by a hospital anxiety and depression questionnaire.

Able to understand and willing to sign informed consent. Females who are nonpregnant, nonlactating, and willing to use a clinically approved methods of contraception two weeks prior to Day 0 until 1 week after the last dose of study medication.

Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00332137
1696-05
Not Provided
Not Provided
Mayo Clinic
Pfizer
Not Provided
Mayo Clinic
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP